Patents form the basis of the pharma and biotech industry, also called the life sciences industry. They give companies an incentive to make large investments in risky drug development and innovations, which have the potential to be ineffective or to fail Food and Drug Administration (FDA) approval. More than 6,000 U.S. businesses spent...

Generic drugs have operated under a different set of rules than brand-name drugs since 1984, when Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act. Brand-name drug manufacturers must submit extensive evidence from clinical trials to get approval from the Food and...

The 2012 Supreme Court got a lot of attention for its decision to uphold most of the Affordable Care Act (ACA) health reform law in NFIB v. Sebelius. But this year’s court docket will be no dud. There will be a number of interesting and important cases for pharma...

As patents on brand-name drugs expire, and generic drug use increases, the United States, Europe, and Japan will account for a smaller share of worldwide spending on prescription drugs, a report from IMS Institute for Healthcare Informatics says. Yet rising incomes in countries such as Russia, China and India...

Prescription drug spending rose by $135 billion between 2001 and 2010 to comprise approximately 12 percent of the nation’s overall healthcare outlay. While drug expenditure was one of the fastest growing components of U.S. healthcare spending prior to the early 2000s, generic drugs helped reduce the rate of annual...

The Patient-Centered Outcomes Research Institute (PCORI) has published its first set of proposed national priorities for research, Draft National Priorities for Research and Research Agenda Version 1. This 22-page publication highlights five focus areas for use in guiding comparative clinical effectiveness research and funding announcements.
The Institute invites comments from...

Direct-to-Consumer (DTC) advertising of prescription drugs, especially new brand-named drugs, remains controversial. Some in Congress remain eager to prohibit advertising of brand-name prescription drugs to consumers in the first two years following a drug’s approval by the Food and Drug Administration (FDA). Is this a good idea or is it...

At the last annual meeting of the Academy of Managed Care Pharmacy, several of us spoke on pharmaceutical research and development in the quickly emerging value-driven healthcare system. Topics focused on the impact of value-based benefit designs, comparative effectiveness research, and government policies on the development of new drugs...

Here are articles from the latest issue of American Health & Drug Benefits. AHDB is a peer-reviewed journal for 30,000 decision makers in health plans, PBMs, Medicare, Medicaid, and the pharma and biotech industries:
June - July 2009 Issue:
Applying Evidence for Medical Technologies: Closing the Gap between R&D and Decision...

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The Piper Report blog on healthcare business and policy covers issues in Medicaid, Medicare, and the Affordable Care Act, with articles, interviews, resources, primers, book reviews, and more. Edited by Kip Piper, MA, FACHE.